Rucha Patel, Manager, Quality Assurance and Regulatory Affairs, MIMOSA Diagnosticspost_market_surveillance_sop_template-1Download To access this post, you must purchase MEMBER PLUS + or MEMBER PLUS 6M FREE.
Created by:Yarismar Fernández-Alicea, EIT, MS, Quality Assurance Specialist, Amgen PRtakeaway_tool_for_the_learn_how_to_effectively_utilize_capa_in_the_complaint_handling_process_session-1Download
Created by:Yarismar Fernández-Alicea, EIT, MS, Quality Assurance Specialist, Amgen PRtakeaway_tool_for_initiating_performing_and_documenting_a_complaint_investigation_-1Download
Created by: Kimberly Wallbank & Nicole DamourProduct complaints and reports of adverse events are unwelcome events at any company, especially if a product recall must be considered. However, these must be handled promptly and with all due diligence to prevent authentic drug- related events from negatively impacting the health and well-being of patients. This article […]
Created by: Chris Gray, Principal Consultant, CAIYour company has received an FDA warning letter, now what? As an organization finds itself in uncharted waters due to inspection results, the leader’s job is to chart a course and speed to re-inspection success without everyone jumping ship. Leaders must remember historical averages for change success hovers between […]
